Amylin's insulin wild card

The only accepted treatment for Type I diabetes is insulin therapy, and many patients with Type II diabetes also receive insulin. The experience of Amylin Pharmaceuticals Inc. at last week's FDA advisory panel meeting indicates that as companies work to develop new hypoglycemic agents for use with insulin, they will face complex treatment issues that may have to be addressed in separate trials. In particular, companies may find that they need to run one kind of trial to show efficacy, and another type of trial to explore how to use new compounds in combination with insulin in real life.

Despite enthusiasm shown by the panel members for AMLN's Symlin pramlintide, the Endocrinologic and Metabolic Advisory Committee voted against approval to treat Type I and Type II diabetes as an adjunct to insulin. While the panel concluded that AMLN demonstrated that pramlintide has efficacy as measured by decreases in glycosylated hemoglobin (HbA1c) in both Type I and Type II patients, it also said the company did not provide sufficient information to guide physicians in the use of pramlintide as an adjunct to insulin. ...